Update to decision to list nitrofurantoin modified-release 100 mg capsules (Macrobid)
Update: 14 April 2022
Medsafe has approved the removal of the in-use shelf life for Macrobid capsules (pharmacode 2493624).
What we’re doing
Nitrofurantoin modified-release 100 mg capsules (Brand name: Macrobid) was listed in Section B of the Pharmaceutical Schedule from 1 March 2021. This decision was notified in October 2020.
PHARMAC has decided to temporarily apply wastage claimable to Te Arai Biofarma’s brand of nitrofurantoin cap modified-release 100 mg (Brand name: Macrobid) from 1 March 2021.
What does it mean for people?
Nitrofurantoin is an antibiotic used to treat urinary-tract infections. This new modified-release presentation, Macrobid, will reduce the frequency of dosing from four times daily with the existing funded presentation (Nifuran) to twice daily. It is expected to benefit over 50,000 patients per year.
Each bottle of Macrobid contains 100 capsules, enough for 10 treatment courses at standard dosing.
Sector feedback on the decision to fund Macrobid was positive; however, concerns were raised about the short in-use shelf life of 30 days and potential impact for pharmacies if there is unused stock 30 days after opening.
On 23 February 2021, Medsafe approved an extension of the in-use shelf life from 30 days to 90 days for Macrobid. This is updated in the Macrobid product datasheet.
The supplier (Te Arai BioFarma) has also initiated a stability study of Macrobid capsules and intends to seek Medsafe approval to remove the in-use shelf life upon successful completion of the study. The results are expected later this year.
To further address the feedback, PHARMAC has temporarily applied the Wastage rule to Macrobid.
Based on the updated 90 day in-use shelf life we expect that there will now be less wastage (if any) and we do not expect wastage to be claimed until at least May 2021. This is a temporary measure to help pharmacies manage the stock effectively and we intend to review this arrangement (which will include an analysis of wastage claims) later this year.
Feedback also commented on having two brands of nitrofurantoin with different dosing regimens (i.e. four times daily for Nifuran and twice-daily for Macrobid). Please ensure that the correct product has been selected when dispensing.
Any other changes to the original decision?
This decision follows the sector feedback from the notification of the decision to fund modified-release nitrofurantoin capsules. There have been no other changes to the decision.
Who we think will be most interested
- Pharmacists and pharmacy staff
Our response to what you told us
We’re really grateful for the time people took to give us feedback on this decision.
If you have any questions about this decision, email: email@example.com